Download PART III: CONSUMER INFORMATION TOPAMAX

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
Pr
TOPAMAX®
topiramate tablets, House Std.
topiramate sprinkle capsules, House Std.
This leaflet is Part III of a three-part "Product Monograph"
published when TOPAMAX® was approved for sale in
Canada and is designed specifically for Consumers. This
leaflet is a summary and will not tell you everything about
TOPAMAX®. Contact your doctor or pharmacist if you
have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
 TOPAMAX® has been prescribed to you/your child to
control epilepsy.

TOPAMAX® may also be prescribed to you to prevent
your migraine headaches if you are an adult patient
(over 18 years of age) with 4 or more attacks per month
and are not responding to acute treatment.
What it does:
TOPAMAX® affects chemicals in the brain that are
involved in sending signals to the nerves. TOPAMAX®
belongs to a group of medicines used to treat epilepsy.
When it should not be used:
 You/your child should not use TOPAMAX® if you are
allergic to any of the ingredients in the product. Contact
your doctor immediately if you experience an allergic
reaction (e.g., skin rash, hives) or any severe or unusual
side effects.
 You should not use TOPAMAX® to prevent your
migraine headaches if you are pregnant or a woman of
childbearing potential and are not using an effective
method of birth control.
 For the prevention of other types of headaches that are
different from migraine attacks.
 For the acute treatment of migraine headache.
What the medicinal ingredient is:
topiramate
What the nonmedicinal ingredients are:
Tablets: carnauba wax, hypromellose (hydroxypropyl
methylcellulose), lactose monohydrate, magnesium stearate,
pregelatinized starch, microcrystalline cellulose,
polyethylene glycol, polysorbate 80, purified water, sodium
starch glycolate, titanium dioxide, and may contain
synthetic iron oxide.
Sprinkle Capsules: black pharmaceutical ink, cellulose
acetate, gelatin, povidone, sorbitan monolaurate, sodium
lauryl sulfate, sugar spheres (sucrose and starch) and
titanium dioxide.
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What dosage forms it comes in:
Tablets: 25 mg, 100 mg, 200 mg
Sprinkle Capsules: 15 mg, 25 mg
WARNINGS AND PRECAUTIONS
BEFORE you use TOPAMAX®, talk to your doctor or
pharmacist if:
 you drive a vehicle, use machines, perform hazardous
tasks during your work or do anything else that could
be dangerous if you are not alert.
 you/your child have or have had kidney stones or
kidney disease. Your doctor may want you to increase
the amount of fluids you/your child drink(s) while
taking this medicine.
 you/your child have or have had liver disease.
 you/your child have or have had depression, mood
problems, or suicidal thoughts or behaviour.
 you/your child have a history of metabolic acidosis (too
much acid in the blood).
 you/your child have weak, brittle, or soft bones
(osteomalacia, osteoporosis, osteopenia, or decreased
bone density).
 you/your child have eye problems, especially glaucoma.
 you/your child have diarrhea.
 you/your child are having surgery.
 you/your child have or have had any medical problems
or allergies.
 you are breast-feeding (nursing). TOPAMAX®
passes into breast milk and can harm your baby.
You and your doctor should decide whether you
should take TOPAMAX® or breast-feed, but not
both.
 you/your child are/is taking medicines that slow down
the nervous system (CNS depressants).
 you/your child are taking oral contraceptives and
TOPAMAX® Tablets or Sprinkle Capsules; tell your
doctor about any changes in your bleeding patterns
(breakthrough bleeding/spotting).
 you are pregnant or plan to become pregnant.
 you are taking a ketogenic diet (a diet high in fat and
low in protein and sugar).
 you consume alcohol regularly.
 you/your child have a growth problem.
EPILEPSY ONLY
 If you take TOPAMAX® during pregnancy, your
baby has a higher risk for birth defects called cleft
lip and cleft palate. These defects can begin early in
pregnancy, even before you know you are pregnant.
 Cleft lip and cleft palate may happen even in
children born to women who are not taking any
medicines and do not have other risk factors.
 There may be other medicines to treat your
condition that have a lower chance of birth defects.
 All women of childbearing age who are being
treated for epilepsy should talk to their healthcare
providers about using other possible treatments
instead of TOPAMAX®. If the decision is made to
use TOPAMAX®, you should use effective birth
control (contraception) unless you are planning to
become pregnant. You should talk to your doctor
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IMPORTANT: PLEASE READ
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about the best kind of birth control to use while you
are taking TOPAMAX®.
Do not stop TOPAMAX® without first talking to a
healthcare provider. Stopping TOPAMAX® suddenly can
cause serious problems including seizures.
Metabolic acidosis may have harmful effects on your
baby. Talk to your healthcare provider if
TOPAMAX® has caused metabolic acidosis during
your pregnancy.
Tell your doctor right away if you become pregnant
while taking TOPAMAX®. You and your doctor
should decide if you will continue to take
TOPAMAX® while you are pregnant.
INTERACTIONS WITH THIS MEDICATION
Pregnancy Registry: If you become pregnant while
taking TOPAMAX®, talk to your doctor about
registering with the North American Antiepileptic
Drug (NAAED) Pregnancy Registry. You can enroll
in this registry by calling 1-888-233-2334. The
purpose of this registry is to collect information
about the safety of antiepileptic medicine during
pregnancy. Information on the registry can also be
found at the website
http://www.massgeneral.org/aed/.
MIGRAINE PROPHYLAXIS
TOPAMAX® is not to be used to prevent migraine
headaches in pregnant women or women of childbearing
potential who are not using an effective method of birth
control.
Other Precautions:
TOPAMAX® may cause some people to be less alert than
normal. Make sure you know how you/your child are/is
affected by this medication before you drive, use machines,
or do anything else that could be dangerous if you are not
alert.
TOPAMAX® may reduce the efficacy of oral contraceptives
even in the absence of breakthrough bleeding. Therefore,
oral contraceptives containing not less than 30 µg of
estrogen should be used.
A very small number of people may have thoughts of
suicide.
TOPAMAX® can increase the level of acid in your blood
(metabolic acidosis). If left untreated, metabolic acidosis
can cause brittle or soft bones (osteoporosis, osteomalacia,
osteopenia), kidney stones, can slow the rate of growth in
children, and can harm your baby if you are pregnant.
Metabolic acidosis can happen with or without symptoms.
Your doctor should do a blood test to measure the level of
acid in your blood before and periodically during your
treatment with TOPAMAX®.
Rarely, blood tests have shown a slight increase in acidity.
In many cases, there are no symptoms from this increased
acidity but some people may experience symptoms such as
rapid breathing, persistent lack of energy and loss of
appetite. Some people may experience more serious
symptoms such as heart problems, confused thinking or
reduced consciousness.
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Tell your doctor about all medications (prescription and
non-prescription) and dietary supplements you/your child
are/is using. It is especially important that your doctor know
if you/your child are/is taking digoxin, oral contraceptives,
glyburide, lithium, risperidone, diltiazem, or any other
antiepileptic drugs, such as phenytoin, valproic acid or
carbamazepine.
PROPER USE OF THIS MEDICATION
TOPAMAX® is usually taken twice a day; however, your
doctor may tell you to take it once a day or at a higher or
lower dose.
Never stop taking, increase or decrease the amount of
TOPAMAX® you are taking unless your doctor tells you to.
Swallow the Tablets or the Sprinkle Capsules and take with
plenty of water. You/your child can take the Tablets or the
Sprinkle Capsules with or without food. Do not break or
crush your tablets. You may swallow the Sprinkle Capsules
whole with water or administer them by carefully opening
the capsule and sprinkling the entire contents on a small
amount (teaspoon) of soft food. This drug/food mixture
should be swallowed immediately and not chewed. It should
not be stored for future use.
Always check that you have enough Tablets or Sprinkle
Capsules and do not run out. Do not suddenly stop taking
this medicine without first checking with your doctor.
EPILEPSY
It is important that you take TOPAMAX® exactly as your
doctor has instructed. Your doctor will start with a low dose
and slowly increase the dose to the lowest amount needed to
control your/your child’s epilepsy.
Usual dose:
TOPAMAX® taken alone: The usual maintenance dose in
adults and children (6 years of age and older) is between
100 mg/day and 400 mg/day. TOPAMAX® is usually taken
twice a day.
TOPAMAX® taken in combination with other antiepileptic
drugs: The usual adult maintenance dose is 200 mg to 400
mg/day.
In children, dosing is based on weight and the dose is
approximately 5 to 9 mg/kg/day.
®
TOPAMAX is not indicated for use in patients under 2
years of age.
MIGRAINE PROPHYLAXIS
It is important that you follow your doctor’s instructions
carefully to help reduce the chances of getting a migraine
headache. Your doctor will start treatment with a dose of 25
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IMPORTANT: PLEASE READ
mg to be taken at night. Your doctor will then increase your
dose to the lowest amount needed to prevent migraine
headaches.
Usual dose:
The usual adult dose is 100 mg per day. TOPAMAX® is
taken twice a day (50 mg in the morning and 50 mg at
night). Your doctor may tell you to use a lower or higher
dose.
frequently reported side effects are: agitation, decrease
in appetite, speech disorders (e.g., hesitancy or wordfinding difficulty), depression, emotional lability, vision
disorders (e.g., double vision), mood swings, nausea,
taste changes, weight loss and kidney stones (may
include symptoms such as blood in the urine, or low
back pain or pain in the genital area).
In children, the following side effects were associated
with the use of TOPAMAX®: difficulty concentrating,
forgetfulness, tiredness, drowsiness, nervousness,
decrease in appetite, weight loss, upper respiratory
tract infection (e.g., colds, bronchitis), headache, fever,
tingling and aggressive behaviour.

®
TOPAMAX is not indicated for the prevention of migraine
attacks in patients under 18 years of age.
Remember: This medicine has been prescribed for
you/your child. Do not give it to anybody else.
Overdose:
In case of a drug overdose, immediately go to the nearest
emergency room even if you do not feel sick. Make sure
you take your medicine bottle with you to show the
doctor.
Missed dose:
If you/your child miss/misses a dose, take it as soon as you
remember. But if it is almost time for the next dose, do not
take the missed dose. Instead, take the next scheduled dose.
Do not try to make up for the missed dose by taking a
double dose next time.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/effect
Only if
severe
Rare
SIDE EFFECTS AND WHAT TO DO ABOUT THEM







Any medicine may have unwanted effects. Tell your
doctor or pharmacist about any unusual sign or
symptom whether listed or not.
Contact your doctor immediately or go to the
Emergency Room if you/your child experience/
experiences sudden worsening of vision, blurred vision
or painful/red eye(s).
TOPAMAX® may cause decreased sweating and
increased body temperature (fever). People, especially
children, should be watched for signs of decreased
sweating and fever, especially in hot temperatures.
Some people may need to be hospitalized for this
condition. Make sure you/your child increase/ increases
and maintain/maintains fluid intake prior to and during
activities such as exercise and exposure to warm
temperatures. Call your doctor right away if you/your
child have/has a fever or decreased sweating.
High ammonia in the blood can affect your mental
activities, slow your alertness, make you feel tired, or
cause vomiting.
Taking TOPAMAX® when you/your child are/is also
taking valproic acid can cause a drop in body
temperature to less than 35ºC (95ºF), a feeling of
tiredness, confusion, or coma.
Drink plenty of fluids when taking TOPAMAX® to
decrease your chances of getting kidney stones.
Side effects reported most often in adults are: coordination problems, difficulty concentrating, slow
thinking, confusion and forgetfulness, dizziness,
tiredness, tingling, headache, upper respiratory tract
infection (e.g., colds, bronchitis) and drowsiness. Less
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Talk with your
doctor or
pharmacist
right away
Very Rare
Kidney stones
(blood in the
urine or pain in
the lower back or
genital area)
Seek urgent
medical
attention
In all
cases

Sudden
worsening of
vision, blurred
vision with
painful/red eye(s),
loss of part of the
field of vision

Decreased
sweating and
increased body
temperature
(fever)

Metabolic
Acidosis
(unexplained
tiredness, loss of
appetite, irregular
heartbeat, and
impaired
consciousness)

Confusion,
problems with
concentration,
attention,
memory, and/or
speech

Thoughts of
suicide or hurting
yourself

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IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
HOW TO STORE IT
•
Symptom/effect
High blood
ammonia (This
happens when
taken with a
medicine called
valproic acid.)
(decreased
alertness,
tiredness or
fatigue, vomiting)
Allergic reaction
(red skin, hives,
itching, swelling
of the lips, face,
tongue, throat,
trouble breathing,
wheezing,
shortness of
breath, skin
rashes, blisters of
the skin, sore
mouth or eyes)
Talk with your
doctor or
pharmacist
right away
Seek urgent
medical
attention
•
•
Do not use this product after the expiry date written on
the package.
Store between 15–30ºC in a dry place.
Keep this and all medicines in a safe place away from
children.

REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated
with the use of health products to the Canada Vigilance
Program by one of the following 3 ways:




Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and
the adverse reaction reporting guidelines are available on
the MedEffect® Canada Web site at
www.healthcanada.gc.ca/medeffect.
Uncommon side effects – between 1 and 10 reports in every 1000
patients exposed
Rare side effects – from 1 to less than 10 reports in every 10,000
patients exposed
Very rare side effects – less than 1 report in every 10,000 patients
exposed
NOTE: Should you require information related to the
management of side effects, contact your health
professional. The Canada Vigilance Program does not
provide medical advice.
This is not a complete list of side effects. If you have any
unexpected effects while taking this drug, contact your doctor
or pharmacist.
MORE INFORMATION
This document plus the full Product Monograph, prepared
for health professionals, can be found at:
http://www.janssen.ca
or by contacting the sponsor, Janssen Inc., at:
1-800-567-3331 or 1-800-387-8781.
This leaflet was prepared by
Janssen Inc.
Toronto, Ontario M3C 1L9
Last revised: March 2015
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